The following data is part of a premarket notification filed by Invamed Technologies Inc. with the FDA for Sppro Esp, Models Esp 603-18-05, Esp 603-18-09.
| Device ID | K032981 |
| 510k Number | K032981 |
| Device Name: | SPPRO ESP, MODELS ESP 603-18-05, ESP 603-18-09 |
| Classification | Needle, Conduction, Anesthetic (w/wo Introducer) |
| Applicant | INVAMED TECHNOLOGIES INC. 9955 TITAN PARK CIRCLE Littleton, CO 80125 |
| Contact | Tim Duvall |
| Correspondent | Tim Duvall INVAMED TECHNOLOGIES INC. 9955 TITAN PARK CIRCLE Littleton, CO 80125 |
| Product Code | BSP |
| CFR Regulation Number | 868.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-24 |
| Decision Date | 2004-04-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B33955625040 | K032981 | 000 |
| B33955222125 | K032981 | 000 |
| B33955223070 | K032981 | 000 |
| B33955322075 | K032981 | 000 |
| B33955322120 | K032981 | 000 |
| B33955323020 | K032981 | 000 |
| B33955323040 | K032981 | 000 |
| B33955325040 | K032981 | 000 |
| B33955422050 | K032981 | 000 |
| B33955423090 | K032981 | 000 |
| B33955522070 | K032981 | 000 |
| B33955522120 | K032981 | 000 |
| B33955623040 | K032981 | 000 |
| B33955222070 | K032981 | 000 |